On December 3, 2020 Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, "Eisai") reported that presentations on a series of abstracts highlighting updates on its in-house discovered lenvatinib mesylate (product name: LENVIMA, the orally available kinase inhibitor, "lenvatinib"), eribulin mesylate (product name: Halaven, halichondrin class microtubule dynamics inhibitor, "eribulin"), and H3B-6545 (selective estrogen alpha receptor covalent antagonist), discovered at Eisai’s U.S. research subsidiary H3 Biomedicine Inc., will be given at the 43rd San Antonio Breast Cancer Symposium (SABCS2020) Virtual Meeting, from December 8 to 11, 2020, in San Antonio, Texas in the United States (Press release, Eisai, DEC 3, 2020, View Source [SID1234574976]).

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At this symposium, regarding the combination therapy with lenvatinib and the anti-PD-1 therapy pembrolizumab (product name: KEYTRUDA) from Merck & Co., Inc., Kenilworth, N.J., U.S.A. (known as MSD outside of the United States and Canada), the results of the triple-negative breast cancer cohort in the basket-type Phase II clinical study (LEAP-005) for 6 types of previously treated, advanced solid tumors (Abstract No: PS12-07) is scheduled to be presented.

The results of analysis evaluating eribulin in the clinical practice in a subgroup of patients with metastatic breast cancer with a poor prognosis, in the United States, (Abstract No: PS13-37) will be published.

In addition, regarding H3B-6545, the results of evaluating tolerability, safety, and efficacy of Phase I/II clinical study for estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (Abstract No: PD8-06) and others will be presented.

In March 2018, Eisai and Merck & Co., Inc., Kenilworth, N.J., U.S.A., through an affiliate, entered into a strategic collaboration for the worldwide co-development and co-commercialization of lenvatinib.

Eisai positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. Eisai will continue to create innovation in the development of new drugs based on cutting-edge cancer research, as it seeks to contribute further to addressing the diverse needs of, and increasing the benefits provided to, patients with cancer, their families, and healthcare providers.

This release discusses investigational compounds and investigational uses for FDA-approved products. It is not intended to convey conclusions about efficacy and safety. There is no guarantee that any investigational compounds or investigational uses of FDA-approved products will successfully complete clinical development or gain FDA approval

Major poster presentations at SABCS2020:
Product / Compound
Abstract No. Title / Scheduled Date and Time (local time: Central Standard Time)
Lenvatinib
PS12-07 Lenvatinib plus pembrolizumab for previously treated, advanced triple-negative breast cancer: Early results from the multicohort phase 2 LEAP-005 study
December 9 (Wed), 8:00 AM
Eribulin
PS13-37 Effectiveness of eribulin in poor prognosis subgroups of metastatic breast cancer (mBC) patients (Elderly, African Americans, and patients with liver metastases) in the United States
December 9 (Wed), 8:00 AM
H3B-6545
PD8-06 Phase I/II Trial of H3B-6545, a novel selective estrogen receptor covalent antagonist (SERCA), in estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer
December 10 (Thu), 2:15-3:30 PM
H3B-6545
PS12-15 Pharmacokinetics of H3B-6545 in Patients with Locally Advanced or Metastatic Estrogen Receptor-Positive HER2 Negative Breast Cancer
(ER+ and HER2- BC)
December 9 (Wed), 8:00 AM
H3B-6545
PS12-23 Development of H3B-6545, a first-in-class oral selective ER covalent antagonist (SERCA), for the treatment of ERaWT and ERaMUT breast cancer
December 9 (Wed), 8:00 AM

On December 3, 2020 Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, reported that the company has received feedback from the U.S. Food and Drug Administration (FDA) and may now proceed with a planned Phase I clinical study of its leading drug candidate, STP705, for treatment of multiple types of liver cancer (Press release, Sirnaomics, DEC 3, 2020, View Source [SID1234574524]).

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The FDA has provided valuable feedback on the company’s proposed trial design for a "Phase 1 Multicenter, Open-Label, Dose Escalation Study and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of STP705 Administered Intratumorally in Cholangiocarcinoma, Hepatocellular Carcinoma or Liver Metastases in Subjects With Advanced / Metastatic or Surgically Unresectable Solid Tumors Who Are Refractory to Standard Therapy." The first patient is expected to be enrolled in the study in the first quarter of 2021. STP705 is a small interfering RNA (siRNA) therapeutic that utilizes a proprietary polypeptide nanoparticle (PNP)-enhanced delivery system to inhibit expression of TGF-β1 and COX-2 in targeted tissue and cells. Preclinical animal models have demonstrated its effective anti-tumor activity for treatments of cholangiocarcinoma and hepatocellular carcinoma.

"Receiving the required feedback from the FDA now permits us to proceed with this Phase I study that represents an important step forward in demonstrating the broader clinical utility of our siRNA therapeutic candidates," said Patrick Y. Lu, PhD, Sirnaomics’ Founder and CEO. "Liver cancer treatment remains a critical unmet need globally and especially in Asian countries. Our clinical strategy leveraging STP705’s FDA Orphan Drug designation for the treatment of cholangiocarcinoma and hepatocellular carcinoma will potentially be highly beneficial to patients suffering these life threatening diseases in both the US and Asia. We are anticipating that this clinical study will contribute to the expanding clinical evidence supporting extensive therapeutic potential of STP705 against various cancers."

"Liver cancer continues to be a devastating disease for patients with high mortality and high unmet medical need," stated Michael Molyneaux, MD, Sirnaomics’ Chief Medical Officer. "This disease fits with Sirnaomics mission to bring lifesaving drugs to patients with severe debilitating medical illness. We hope to gain important insight into the potential safety and efficacy of STP705 in this Phase I trial and we expect to build on the data from this study to expand into other oncology indications."

About Liver Cancer

Liver cancer is a global health problem, with liver neoplasms representing the second-most frequent cause of cancer-related death There are many different types of liver cancers including hepatocellular carcinoma (HCC), cholangiocarcinoma (CCA), liver angiosarcoma, hepatoblastoma and others. Additionally, liver is a highly metastasis-permissive organ. It is the most frequently afflicted organ by metastasis and liver metastases are much more common than primary hepatic tumors. The distinctive biology of the liver renders it intrinsically susceptible to metastases. The true prevalence of liver metastasis is unknown, but between 30% and 70% of patients dying of cancer have liver metastases and most patients with liver metastases will die of their disease.

STP705 and Liver Cancer

Over expressions of TGF-β1 and COX-2 have been well-characterized as playing key regulatory roles in tumorigenesis. TGF-β is produced by different liver cells and is demonstrated to induce tumor cell migration and survival. TGF-β has been found to be overexpressed in metastatic HCC tissues. Overexpression of TGF-β is generally accepted to be associated with metastasis and poor prognosis. COX-2 is reported to be highly expressed in cancer stem cells and promotes cell migration in HCC cell lines. Additionally, inhibition of COX-2 suppresses cell migration and induces apoptosis. As such TGF-β1 and COX-2 are excellent therapeutic targets for treatment of liver cancer.

STP705 is composed of two siRNA oligonucleotides targeting TGF-β1 and COX-2 mRNA respectively and formulated in nanoparticles with a proprietary Histidine-Lysine Co-Polymer (HKP) peptide. Each individual siRNA has demonstrated the ability to inhibit the expression of their target mRNA and combining the two siRNAs produces a synergistic effect that diminishes pro-fibrogenic, pro-inflammatory, and pro-tumorigenic factors. Sirnaomics has completed numerous pre-clinical studies that demonstrate that inhibition of TGF-β1 and COX-2 is expected to result in the inhibition of tumor growth and provide an alternative approach for the treatment of various liver cancers. Molecular analyses of the effects of administering the combination demonstrated that the inhibition of these targets had effects on downstream gene products associated with numerous oncology targets. Additional immunohistochemistry and image analyses of the liver and tumor tissues demonstrated that animals treated with STP705 resulted in increased CD4+ and CD8+ T cell infiltration within the tumor microenvironment. Using STP705 for treatments of hepatocellular carcinoma and cholangiocarcinoma have been designated as Orphan Drug indications by U.S. FDA. STP705 has also been evaluated in a Phase IIa clinical trial for treatment of Non-melanoma skin cancer.

On December 3, 2020 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that members of the management team will present the company at the following virtual conferences (Press release, BerGenBio, DEC 3, 2020, View Source [SID1234574330]):

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The Nordic-American Life Science Conference

Global Markets Day section

Date: 3rd December 2020

Time: 8AM – 12PM EST

Further information can be found here: View Source
-americanlifescience.com/

DNB Nordic Healthcare Conference

The DNB Markets Session

Date: 15th December 2020

Time: Live webcasts from 9AM CET

Further information can be found here: View Source

The presentations will be made available at www.bergenbio.com after the events.

On December 3, 2020 Dr. Michael Spinner, from Stanford University, Department of Medicine, Division of Oncology, reported that it will present at the 2020 Virtual ASH (Free ASH Whitepaper) Annual Meeting an update to the recently published article in Blood Advances (Press release, Notable Labs, DEC 3, 2020, View Source [SID1234572228]). This study used Notable Labs’ fully automated ex vivo drug sensitivity screening platform to test living tumor biopsies from patients with MDS and related myeloid neoplasms, and to identify correlations between clinical and genomic features and ex vivo drug sensitivity. Titled Correlating Clinical and Genomic Features with Ex Vivo Drug Sensitivity in Patients with Myelodysplastic Syndromes and Related Myeloid Neoplasms, this follow-up analysis involved patients evaluated at Stanford MDS Center between 2016-2020 with a diagnosis of MDS, MDS/MPN, or secondary AML. Ex vivo drug sensitivity screening defined three distinct patient clusters with differential sensitivity to numerous drug classes. Specific mutations were associated with greater ex vivo sensitivity to specific drug classes.

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To hear more about this exciting study and more, visit the virtual poster hall on Monday, December 7th from 7:30 am-3:30 pm PST.

Our Notable team will be attending ASH (Free ASH Whitepaper) this year. Schedule a meeting with our team and learn more about Notable’s proprietary automated, high-throughput, high-content, ex-vivo functional screening platform using living tumor biopsies.

On December 3, 2020 Silverback Therapeutics reported that it has upped the ante on their IPO not once but twice, from an initial $125 million raise, to $151.8 million, to now setting sights on a $195 million raise, a 56% increase (Press release, Silverback Therapeutics, DEC 3, 2020, View Source [SID1234572211]). The firm will offer 10 million shares at a range of $19 to $20 apiece.

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Silverback’s technology, ImmunoTAC, distinguishes itself from the competition by developing therapies that act only at the sites of disease, sparing healthy tissues from unwanted side effects. The platform pairs payloads that modulate disease-modifying pathways with monoclonal antibodies directed at specific disease sites. Its new class of targeted immuno-oncology agents direct a myeloid cell activator, which can permeate even solid tumors that are resistant to T-cell targeted immunotherapies.

The biotech’s pipeline is made up of TLR8 agonist candidates, with the lead currently in Phase I clinical study as a monotherapy to activate human myeloid cells in HER2-expressing tumors. Preclinical data on SBT6050 showed potential to maximize anti-tumor immune responses, even in tumors lacking T-cells. An update of interim data is expected in the second half of 2021.

This year has already brought in a good chunk of change for Silverback. In March, their oversubscribed Series B raked in $78.5 million. Then September brought the biotech $85 million more in a Series C. With a successful IPO, the company will have raised $405 million since its 2016 launch.

With industry-veteran Laura Shawver at the helm, Silverback hopes to prove their merit in treating highly prevalent forms of cancer – breast, gastric, NSCLC, bladder, TNBC, head & neck and other solid tumors.

After their most recent Series C, Shawver said, "Our new investors understand our fundamental science, our goal to help cancer patients, and the value creation potential of our programs. It’s awesome to have new partners in our journey along with current investors!"

Even amidst a deadly pandemic, Silverback’s announcement brings the biotech IPO record-breaking total to around 65 biotechs according to a tracker on BioPharma Dive. And the year isn’t quite over yet. Compared to the 38 biotech IPOs in 2019 and 45 in 2018, 2020 has the Nasdaq’s head spinning.

The company will trade under the symbol SBTX with Goldman Sachs, SVB Leerink and Stifel as joint bookrunners on the deal.